Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation.
FDA Recall Z-2010-2009 · Posted 2009-09-03
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Recalling FirmInstrumentation Industries Inc
Recall StatusTerminated
Product CodeBTO
Date Initiated2009-07-09
Date Terminated2009-10-15
Product Quantity396 units
Reason for Recall
user instructions not updated to correspond with product change
Firm Action
Instrumentation Industries, Inc. issued a notification letter dated July 9, 2009 to their customers explaining the problem and the need to replace current inventory user instructions with the revised user instructions accompanying the letter.
For further questions, contact Instrumentation Industries, Inc. at 1-800-633-8577.
Root Cause
Component change control
Distribution Pattern
Nationwide Distribution -- AK, AL, AR, CA, CO, FL, GA, IA, ID, IL,IN, MA, MD, ME, MI, MN, NC, ND, NH, NJ, OH, PA, SC, SD, TX, VA and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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